"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)

NCT04503564 | Completed Results FDA Device

• 2 other identifiers: 150-1072-00ACTRN12620000021976
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using continuous subcutaneous insulin infusion with an infusion set that needs to be changed every 3 days. This study will assess the feasibility and device performance of the study device, the Achilles infusion set over three periods during routine insulin infusion. This study will include 20 participants and has 3 periods: Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7 days): participants will manage their blood glucose solely with their insulin pump and the Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose monitoring (CGM) device. Period 3 (up to 7 days): Participants will return to study center to receive a fresh Achilles infusion set and continue blood glucose management at home until infusion set failure or 7 days.

Conditions

Diabetes Mellitus, Type 1; Type 1 Diabetes; Type 1 Diabetes Mellitus; Diabetes Mellitus, Insulin-Dependent, 1

Outcome Measures

Primary Outcomes (1)

• Rate of Infusion Set Survival at End of Day 7

  The composite primary objective of this study is to evaluate feasibility and device performance of the Achilles infusion set over three extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion.

  7 days during weeks 2 and 3

Study Arms (1)

Achilles Infusion Set

EXPERIMENTAL

Coil-reinforced soft polymer indwelling cannula

Device: coil-reinforced soft polymer indwelling cannula

Interventions

coil-reinforced soft polymer indwelling cannula DEVICE

This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).

Achilles Infusion Set

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is 18 - 70 years of age inclusive
• Participant is in generally good health, as determined by the investigator
• Participant is willing and able to individually complete written informed consent and agrees to comply with all study related testing and examinations
• Participant must be geographically stable (e.g., expects to be available and capable of returning for all study specified test and examinations) during the study period
• Participant has been diagnosed with T1DM for at least 12 months
• C-peptide less than 0.6 nmol per L at screening
• Subject can provide a minimum of 14 days of insulin pump data to demonstrate pump use compliance
• Participant is willing to perform serum ketone measurements whenever the blood glucose is determined to be greater than 250 mg per dL (14 mmol per L) using a ketone meter and strips provided by the sponsor
• Participant has BMI in the range 20 - 35 kg per square metre inclusive
• Participant has experience infusing a rapid-acting insulin analog for at least 6 months
• Participant has been using an insulin pump with commercially available infusion sets for at least 6 months (this includes Automated Insulin Delivery systems)
• Participant has previous experience using a continuous glucose monitor (CGM) and is willing to use a CGM for the duration of the study and perform necessary calibration fingerstick glucose readings
• Participant has ability to understand and comply with protocol procedures and to provide informed consent
• AST and ALT less than or equal to 120 U per L
• Creatinine less than 1.8 mg per dL

You may not qualify if:

• Participants whose average total daily insulin dose exceeds 85 units per day (i.e. typically change insulin reservoirs more often than every 3.5 days on average)
• Participants who routinely change their commercial insulin infusion sets twice weekly or less often (wear time greater than 3.5 days)
• Female participant is pregnant or nursing (Documented negative pregnancy test results for female participants required unless participant is menopausal without any spontaneous menstrual cycles for \>12 months or key organs have been removed.)
• Participant has abnormal skin at intended device infusion sites (existing infection, inflammation, burns, or other extensive scarring)
• Participant has HbA1C greater than 8.5 percent at screening
• Participant has documented history in last 6 months of severe hypoglycemia associated with cognitive dysfunction sufficiently severe to require third party intervention or a history of impaired awareness of hypoglycemia.
• Participant has a history of diabetic ketoacidosis in the last 6 months
• Participant has known cardiovascular disease considered to be clinically relevant by the investigator
• Participant has known arrhythmias considered to be clinically relevant by the investigator
• Participant has known history of:
• Cushing's Disease,
• pancreatic islet cell tumor, or
• insulinoma
• Participant has:
• Lipodystrophy,

Sponsors & Collaborators

• Capillary Biomedical, Inc.: lead

Study Sites (1)

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Melbourne, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Capillary BioMedical, Inc.

alayne.lehman@capillarybio.com

949-317-1711

Study Officials

• David O'Neal, M.D.

  St Vincent's Hospital Department of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is designed as a single arm device feasibility evaluation

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: August 7, 2020
• Study Start: November 13, 2019
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)